Received Dec 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
got Covid and almost died; got Covid and almost died; CAMPAIGN TRACKER This is a solicited report received from a Consumer or other non HCP, Program ID. A 67-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant, life threatening), COVID-19 (medically significant, life threatening), outcome "unknown" and all described as "got Covid and almost died". Clinical course: The patient stated "need to get the Covid vaccine because she had gotten Covid vaccine before and then got Covid and almost died". The reporter's assessment of the causal relationship of "got covid and almost died" with the suspect product(s) BNT162b2 omicron (lp.8.1) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (COVID-19) with the suspect product BNT162B2 OMICRON (LP.8.1) cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.